Ethical Review of a Multicentre Study in Scotland: A Weighty Problem

Abstract

To assess the current working practices of local research ethics committees (LRECs) in their review of a multicentre study approved by the new multicentre research ethics committee in Scotland. Observational data collected from correspondence with LRECs. All LRECs within the geographical area of the study in Scotland. None. Delay from application to calling an LREC meeting, to an initial LREC decision, to final LREC approval, and the number of A4 pages required. The median delay to review of an application at an LREC meeting was 28 days (range 14-97), the median delay from application to the time of LREC final approval was 39 days (range 21-109) and a total of 5,789 A4 pages (26.9 kg) were required to complete the application process. Despite recent standardisation of ethical review of multicentre research, elimination of unnecessary delay, cost and variation in LREC operating procedures is still necessary.